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Unformatted text preview: rmacokinetic studies investigating the bioequivalence of generic and branded formulations are needed. The purpose of this study was to evaluate and compare the pharmacokinetic properties, bioavailability, and bioequivalence of a 10 mg formulation of montelukast sodium with those of an established branded formulation in healthy Pakistani adult male volunteers. Twenty healthy volunteers received a single oral dose of 10 mg montelukast either as test or as reference tablet in a randomized, open labeled, two -way cross over study. Montelukast in human plasma was determined by HPLC method. The plasma concentration–time curves were used to obtain pharmacokinetic pa rameters. The criteria for bioequivalence were 90 % CIs of 80 to 125 % for AUC and Cmax, according to the International guidelines. -1 Mean maximum concentration (Cmax) of montelukast was 89 µg L at 3.17 hours for test tablets and 104 -1 µg L at 3.33 hours for reference tablets. Mean area under the plasma concentration -time curve from -1 -1 zero to last measured point (AUC0-t) was 753 µg h L for test compared with 865 µg h L for reference. On analysis of variance, no period, formulation or sequence effects were observed for any pharmacokinetic property. All 90 % confidence intervals (CIs) of the test/reference geometric mean ratio were within the bioequivalence limits. In the present bioequivalence study in healthy Pakistani adult male volunteers, a single 10 mg dose of the test formulation of montelukast sodium met the regulatory criteria for bioequivalence to the established reference formulation based on the rate and extent of absorption. Both formulations were well tolerated. 70 3rd ICYC 2010 Universiti Sains Malaysia ANA-O15 23rd-25th June 2010 PROXIMATE COMPOSITION AND MINERAL CONTENTS OF TEN SELECTED RICE (ORYZA SATIVA) VARIETIES OF PAKISTAN Muhammad Zubair and Farooq Anwar Department of Chemistry and Biochemistry, University of Agriculture, Faisalabad, Pakistan E-mail: firstname.lastname@example.org Rice (Oryza sativa) is a...
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This note was uploaded on 02/17/2011 for the course CHEMISTRY 101 taught by Professor Csr during the Spring '11 term at University of Louisville.
- Spring '11